Summary

Researchers and universities are concerned that new U.S. ethics rules will hamper biomedical research that relies on leftover tissue, blood, and urine samples from patients. The changes, proposed last fall by the Department of Health and Human Services (HHS), affect the so-called Common Rule, which protects human research subjects. A key provision would bestow on anonymous biological specimens—those stripped of identifying information such as the patient's name and address—the same ethical status as a living person. As a result, doctor's offices would ask patients for written consent for the broad use of their deidentified samples in future research. Some patient advocacy groups and bioethicists welcome the new rule, saying it is necessary to protect privacy and patient rights. But research institutions warned last week that the changes would create an expensive logistical nightmare—and asked HHS to reconsider.